- Route and method of investigational medicinal product (IMP) administration – clarification of the definition of injection area and injection site within that area. - Timing of IMP injection – clarification of the window for timing of IMP injections. - Adjustment of IMP – clarification of titration beyond 6 to 8 weeks. - Non-investigational medicinal product (NIMP) – emphasis of the need to avoid daytime hypoglycemia, specific guidance on when to begin optimization of the mealtime insulin dose, recording of all doses of mealtime insulin analog. - Review of severe hypoglycemia classification by external Review Board – all hypoglycemia events reported by Investigator as severe and/or reported as serious adverse events (SAEs) were to be independently reviewed by a Severe Hypoglycemia Review Board (SHRB) blinded to treatment arm. This was to ensure consistent use of the severe hypoglycemia classification according to American Diabetes Association definition across the study. Both the Investigators’ classification and the Review Board’s assessment were to be reported. - Screening period – clarification that screening period could be extended from 2 to 3 weeks. - SMPG and change to the scope of data recorded into the electronic case report form upon phone call visits – clarification of documentation of SMPG. Furthermore, in order to reduce burden to subjects and minimize potential for transcription errors, the amount of SMPG data to be collected during phone call visits was reduced to the minimum required for the IMP dose adjustment. However, the remaining SMPG as well as IMP and mealtime insulin dose data of the week prior to the phone call visits recorded by the subject in the diary, were collected at the subsequent on-site visits. - Reporting of SAE and adverse events of special interest (AESI) – clarification of the process of SAE and AESI reporting.